[Remote] QC Reviewer at Thermo Fisher Scientific

Pennsylvania, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Associate/Bachelor’s Degree in Science, or an engineering discipline
2-3 years of previous experience that provides the knowledge, skills, and abilities to perform the job
Master's degree and related experience
Proficiency with MS Word, Excel, PowerPoint
Knowledge, skills, and abilities of Good Manufacturing Practices and Good Documentation Practices in a pharmaceutical environment

Responsibilities

Interact with internal multidisciplinary teams to ensure successful delivery schedules of documents used in the preparation of regulatory filings
Verify data in regulatory submissions matches data in source documents
Verify data in source documents matches data
Identify gaps where documents are not available or complete
Communicate any discrepancies with the parties involved and take steps to correct them in a timely manner
Perform a check of the current data to ensure that it is accurate, consistent, and reflects its intended purpose
Assess procedures for accuracy, simplicity, and practicality and influences changes as appropriate
Build and maintain good working relationships with internal and external partners
Manage issues and risks identified in area of responsibility
Evaluate laboratory data for compliance with analytical methods and SOPs
Review sample results for completeness and accurate representation of the data
Report findings to the project leader for correction
Prepares QC statements noting deficiencies with the analytical data set or notebooks
Reports deficiencies to the project leader for correction
Communicates with laboratory staff to proactively address the quality of laboratory documentation

Skills

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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